Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 1 of 32
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`NICHOLAS A. TRUTANICH
`United States Attorney
`District of Nevada
`Nevada Bar. No. 13644
`ALLISON C. REPPOND
`Assistant United States Attorney
`U.S. Attorney’s Office
`501 Las Vegas Boulevard South, Suite 1100
`Las Vegas, Nevada 89101
`Ph: 702-388-6336
`Email: allison.reppond@usdoj.gov
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`Attorneys for the United States
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`UNITED STATES DISTRICT COURT
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`Case No.: 2:21-cv-00184
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`
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`Complaint
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`DISTRICT OF NEVADA
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`United States of America,
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`Plaintiff,
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`v.
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`PCPLV LLC d/b/a Pinnacle
`Compounding Pharmacy, Ofir Ventura,
`Cecilia Ventura, Brandon Jimenez, Robert
`Gomez, Gomez & Associates, Inc., Rock’n
`Rob Enterprises, Amir Shalev, D.P.M., AS
`Enterprises, Inc., and Ivan Lee Goldsmith,
`M.D.;
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` Defendants.
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`The United States of America (“the United States” or the Government”), on behalf
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`of the United States Department of Defense (“DOD”) and the United States Department of
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`Veterans Affairs (“VA”), brings this action against defendants PCPLV LLC d/b/a Pinnacle
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`Compounding Pharmacy, Ofir Ventura, Cecilia Ventura, Brandon Jimenez, Robert Gomez,
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`Gomez & Associates, Inc., Rock’n Rob Enterprises, Amir Shalev, D.P.M., AS Enterprises,
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`Inc., and Ivan Lee Goldsmith, M.D. (collectively referred to herein as “Defendants”), and
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`alleges as follows:
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 2 of 32
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`I.
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`Introduction
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`1.
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`This is a civil action brought by the United States against the defendants
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`under the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733, and the common law, to
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`recover treble damages sustained by, and civil penalties and restitution owed to, the United
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`States for Defendants’ illegal conduct.
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`2.
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`Between February 2015 and November 2015, Defendants Ofir Ventura and
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`Cecilia Ventura (collectively referred to herein as “the Venturas”) and Brandon Jimenez
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`(“Jimenez”), were all co-owners and members of PCPLV LLC d/b/a Pinnacle
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`Compounding Pharmacy (“Pinnacle”). The owners and members of Pinnacle knowingly
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`and willfully engaged in illegal kickback schemes pursuant to which they caused Pinnacle to
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`pay substantial kickbacks to various third-party marketers in exchange for those marketers
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`arranging for the referral of prescriptions for compounded drugs1 to Pinnacle. The kickbacks
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`paid to these marketers consisted of a substantial share of the revenue that the marketers’
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`referrals generated for Pinnacle. These arrangements violated the Anti-Kickback Statute
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`(“AKS”), 42 U.S.C. § 1320a-7b(b).
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`3.
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`Defendant Robert Gomez, in his individual capacity and as owner of Gomez
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`& Associates, Inc., and Rock’n Rob Enterprises (collectively referred to herein as
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`“Gomez”), was among the third-party marketers that knowingly and willfully received
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`illegal kickbacks from Pinnacle through his corporate entities. Pursuant to those agreements,
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`Gomez carried out campaigns to directly solicit patients, including TRICARE beneficiaries
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`and beneficiaries of the Civilian Health and Medical Program of the Department of
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`Veterans Affairs (“CHAMPVA”), to accept prescriptions for compounded medications, and
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`1 Compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients
`of a drug in response to a prescription to create a medication tailored to the medical needs of an
`individual patient. See U.S. Food & Drug Administration, Compounding and the FDA: Questions
`and Answers,
`https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-
`questions-and-answers (last visited Jan. 28, 2021). For example, a patient with an allergy to a
`particular ingredient in a commercially-available medication may benefit from a compounded
`medication in certain circumstances. Id. Compounded medications often come in the form of
`topical creams or sprays. Compounded medications are typically much more expensive than
`commercially-available medications.
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 3 of 32
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`arranged for those prescriptions to be referred to Pinnacle, which agreed to pay substantial
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`kickbacks in return. Some patients were even offered financial compensation by third-party
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`marketers, including Gomez, for agreeing to accept prescriptions for compounded medicine.
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`Gomez, through his corporate entities, paid illegal kickbacks to patients in exchange for
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`their agreement to try compounded medications from Pinnacle. Gomez also knowingly and
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`willfully paid illegal kickbacks to physicians directly in exchange for the physicians’ writing
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`prescriptions for compounded mediations to be referred to Pinnacle, including Ivan Lee
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`Goldsmith, M.D. (“Goldsmith”), Amir Shalev, D.P.M. (“Shalev”), some of which were
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`paid to AS Enterprises, Inc. (“AS Enterprises”), a corporation in which Shalev served as a
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`director at all relevant times herein.
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`4.
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`Upon information and belief, the Venturas and Jimenez likewise knowingly
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`and willfully engaged in illegal kickback schemes pursuant to which they caused Pinnacle to
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`pay physicians directly for the referral of prescriptions for compounded drugs to Pinnacle.
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`For example, Ofir Ventura and Brandon Jimenez hosted dinners with physicians who
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`prescribed a large number of compounded drugs to Pinnacle, including Goldsmith and
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`Shalev. Upon information and belief, the Venturas and Jimenez knowingly and willfully
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`caused Pinnacle to directly pay illegal kickbacks to AS Enterprises to induce Shalev to
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`continue writing numerous prescriptions for expensive and unnecessary compounded
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`medications from Pinnacle. Pinnacle’s third-party marketer, Gomez, also knowingly and
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`willfully engaged in illegal kickback schemes with physicians and, through his corporations,
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`made payments directly to physicians, including Goldsmith and Shalev, in exchange for
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`these physicians writing numerous prescriptions for Pinnacle’s compounded medications.
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`The kickbacks paid to these physicians likewise consisted of a substantial share of the
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`revenue that the physicians’ prescriptions generated for Pinnacle. These arrangements also
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`violated the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b).
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`5.
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`Through these schemes, Defendants knowingly presented and/or caused to
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`be presented claims to the TRICARE and CHAMPVA programs that were false or
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`fraudulent because they were tainted by kickbacks to marketers, physicians, and patients,
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 4 of 32
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`and did not arise from a valid prescriber-patient relationship and were otherwise
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`unnecessary. As a result of this conduct, Defendants are liable under the False Claims Act,
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`31 U.S.C. § 3729, et seq. (the FCA), and the federal common law.
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`II.
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`Jurisdiction and Venue
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`6.
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`This Court has subject-matter jurisdiction over this action pursuant to 28
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`U.S.C. §§ 1331 and 1345 and 31 U.S.C. § 3732(a) and (b).
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`7.
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`This Court has personal jurisdiction over defendants under 31 U.S.C. §
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`3732(a), because they have adequate minimum contacts with the United States of America
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`and the State of Nevada to make the assertion of personal jurisdiction sufficient to satisfy
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`due process.
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`8.
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`Venue is proper in this action in the District of Nevada under 28 U.S.C. §
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`1391(b) – (c) and 31 U.S.C. § 3732(a), because Defendants can all be found in, reside in, or
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`have transacted business within this Court’s jurisdiction, and acts that they committed in
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`violation of the FCA, AKS and federal common law occurred within this district.
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`III. The Parties
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`9.
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`Plaintiff in this action is the United States of America, suing on behalf of its
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`agencies the DOD, including DOD component the Defense Health Agency (“DHA”),
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`which administers the TRICARE program, and the VA, including VA component the
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`Veterans Health Administration Office of Community Care (“VHAOCC”), which
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`administers the CHAMPVA program.
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`10. At all times relevant herein, Defendant PCPLV LLC, d/b/a Pinnacle
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`Compounding Pharmacy was a Nevada limited liability company with its operations based
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`in Las Vegas, Nevada. At all times relevant to this Complaint, Pinnacle was engaged in the
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`business of providing medical care to, among others, individuals who were TRICARE and
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`CHAMPVA beneficiaries. At all times relevant to this Complaint, Pinnacle acted by and
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`through its vice principals, Ofir Ventura, Cecelia Ventura, and Brandon Jimenez.
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`11. Defendant Ofir Ventura, who resides in Las Vegas, Nevada, was, at all times
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`relevant herein, a co-owner, member, and/or officer of Pinnacle. Ofir Ventura was actively
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 5 of 32
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`involved in managing and directing the daily operations at Pinnacle. At all times relevant
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`herein, Ofir Ventura acted in his capacity as a vice principal of Pinnacle. Ofir Ventura is
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`also liable in his individual capacity for the conduct alleged herein, as he knowingly and
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`willfully made or caused to be made false claims for payment to the United States through
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`and on behalf of Pinnacle in violation of the AKS
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`12. Defendant Cecilia Ventura, who resides in Las Vegas, Nevada, was, at all
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`times relevant herein, the Manager of Pinnacle, as well as a co-owner, member, and/or
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`officer of Pinnacle. Cecilia Ventura was actively involved in managing and directing the
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`daily operations at Pinnacle, including in submitting claims for payment. At all times
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`relevant herein, Cecelia Ventura acted in her capacity as a vice principal of Pinnacle.
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`Cecelia Ventura is also liable in her individual capacity for the conduct alleged herein, as
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`she knowingly and willfully made or caused to be made false claims for payment to the
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`United States through and on behalf of Pinnacle in violation of the AKS.
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`13. Defendant Brandon Jimenez, who resides in Las Vegas, Nevada, was, at all
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`times relevant herein, a co-owner, member, and/or officer of Pinnacle. Jimenez was
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`actively involved in managing and directing the daily operations at Pinnacle. At all times
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`relevant herein, Brandon Jimenez acted in his capacity as a vice principal of Pinnacle.
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`Jimenez is also liable in his individual capacity for the conduct alleged herein, as he
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`knowingly and willfully made or caused to be made false claims for payment to the United
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`States through and on behalf of Pinnacle in violation of the AKS.
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`14. Defendant Robert Gomez, who resides in Las Vegas, Nevada, was, at all
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`times relevant herein, the President, Secretary, Treasurer, and/or a Director, as well as a co-
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`owner, of Gomez & Associates, Inc. and Rock’n Rob Enterprises. Gomez was actively
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`involved in managing and directing the daily operations at Gomez & Associates, Inc., and
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`Rock’n Rob Enterprises. At all times relevant herein, Robert Gomez acted in his capacity as
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`a vice principal for Rock’n Rob Enterprises and Gomez & Associates, Inc. to cause these
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`corporations to pay and receive illegal kickbacks. Gomez is also liable in his individual
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`capacity for the conduct alleged herein, as he knowingly and willfully caused the submission
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`of false claims for payment for payment to the United States in violation of the AKS.
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`15. At all times relevant herein, Defendant Gomez & Associates, Inc., was a
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`Nevada corporation with its principle place of business in Henderson, Nevada. Gomez &
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`Associates, Inc., marketed topical compounded prescription creams and other
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`pharmaceutical products directly to patients throughout the United States, including
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`TRICARE and CHAMPVA beneficiaries and paid and received illegal kickbacks for
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`referrals to federal healthcare programs. At all times relevant to this Complaint, Gomez &
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`Associates acted by and through its vice principal, Gomez.
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`16. At all times relevant herein, Rock’n Rob Enterprises, was a Nevada
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`corporation with its principle place of business in Henderson, Nevada. Rock’n Rob
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`Enterprises marketed topical compounded prescription creams and other pharmaceutical
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`products directly to patients throughout the United States, including TRICARE and
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`CHAMPVA beneficiaries, and paid and received illegal kickbacks for referrals to federal
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`healthcare programs. At all times relevant to this Complaint, Rock’n Rob Enterprises acted
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`by and through its vice principal, Gomez.
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`17. Defendant Amir Shalev, D.P.M. (“Shalev”), was, at all times relevant herein,
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`a Doctor of Podiatric Medicine licensed to practice in the State of Nevada, and a director
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`and owner of AS Enterprises, Inc. Shalev prescribed topical compounded prescription
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`creams and other pharmaceutical products directly to patients throughout the United States,
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`including TRICARE and CHAMPVA beneficiaries. At all times relevant herein, Shalev
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`also acted in his capacity as a vice principal for AS Enterprises, Inc. which received
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`kickback payments for the unnecessary prescriptions Shalev wrote. Shalev is also liable in
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`his individual capacity for the conduct alleged herein, as he knowingly and willfully caused
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`the submission of false claims for payment for payment to the United States in violation of
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`the AKS.
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`18. Defendant AS Enterprises, Inc. is a Nevada corporation with its principle
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`place of business in North Las Vegas, Nevada. Shalev was compensated through illegal
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`kickback payments to AS Enterprises, Inc., by Pinnacle and Gomez in exchange for
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`prescribing topical compounded prescription creams and other pharmaceutical products
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`directly to patients throughout the United States, including TRICARE and CHAMPVA
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`beneficiaries. At all times relevant to this Complaint, AS Enterprises, Inc., acted by and
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`through its vice principal, Shalev.
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`19. Defendant Ivan Lee Goldsmith, M.D. (“Goldsmith”), was, at all times
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`relevant herein, a Doctor of Medicine licensed to practice in the State of Nevada. Goldsmith
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`prescribed topical compounded prescription creams and other pharmaceutical products
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`directly to patients throughout the United States, including TRICARE and CHAMPVA
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`beneficiaries. Goldsmith received illegal kickback payments for writing these prescriptions.
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`IV. Background
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`A.
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`The False Claims Act and Anti-Kickback Statute
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`20.
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`The FCA provides, in part, that any entity that (1) knowingly presents, or
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`causes to be presented, a false or fraudulent claim for payment or approval; or (2) knowingly
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`makes, uses, or causes to be made or used, a false record or statement material to a false or
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`fraudulent claim, is liable to the United States for damages and penalties. 31 U.S.C. §§
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`3729(a)(1)(A)-(B).
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`21.
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`To show that an entity acts “knowingly” under the FCA, the United States
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`must prove that the entity, with respect to the information: (1) has actual knowledge of the
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`falsity of the information; (2) acts in deliberate ignorance of the truth or falsity of the
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`information; or (3) acts in reckless disregard of the truth or falsity of the information. The
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`United States is not required to prove that the entity had the specific intent to defraud the
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`United States. 31 U.S.C. § 3729(b)(1).
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`22. A claim for reimbursement from a federal health care program, including the
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`TRICARE and CHAMPVA programs, for items or services resulting from a violation of the
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`AKS “constitutes a false or fraudulent claim for purposes of [the False Claims Act].” 42
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`U.S.C. § 1320a-7b(g).
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 8 of 32
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`23.
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`The AKS arose out of congressional concern that financial inducements may
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`corrupt referral decisions, undermine the goals of ensuring fair competition for federal funds
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`and a market driven by quality of care rather than financial incentives, impose higher costs
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`on federal health care programs, and divert federal funds towards goods and services that
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`are medically unnecessary, of poor quality, or even harmful to patients. To protect the
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`federal health care programs from these harms, Congress enacted a prohibition against
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`offering, soliciting, paying, or receiving kickbacks in any form. Specifically, the AKS makes
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`it illegal for an individual or entity to knowingly and willfully:
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`[S]olicit[] or receive[] any remuneration (including any kickback, bribe, or
`rebate) directly or indirectly, overtly or covertly, in cash or in kind—
`(A) in return for referring an individual to a person for the furnishing or
`arranging for the furnishing of any item or service for which payment may be
`made in whole or in part under a Federal health care program, or
`(B) in return for purchasing, leasing, ordering, or arranging for or
`recommending purchasing, leasing, or ordering any good, facility, service, or
`item for which payment may be made in whole or in part under a Federal
`health care program.
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`The AKS also makes it illegal for an individual or entity to knowingly and willfully:
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`[O]ffer[] or pay[] any remuneration (including any kickback, bribe, or rebate)
`directly or indirectly, overtly or covertly, in cash or in kind to any person to
`induce such person—
`(A) to refer an individual to a person for the furnishing or arranging for the
`furnishing of any item or service for which payment may be made in whole or
`in part under a Federal health care program, or
`(B) to purchase, lease, order, or arrange for or recommend purchasing,
`leasing, or ordering any good, facility, service, or item for which payment
`may be made in whole or in part under a Federal health care program.
`Id. § 1320a-7b(b).
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`24.
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`The AKS contains several statutory exceptions setting forth certain
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`circumstances under which the AKS’s prohibitions against remuneration do not apply. See
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`42 U.S.C. § 1320a-7b(b)(3). Additionally, the United States Department of Health and
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`Human Services Office of Inspector General has promulgated “safe harbor” regulations that
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`identify payment practices that are not subject to the AKS because such practices are
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 9 of 32
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`unlikely to result in fraud or abuse. See 42 C.F.R. § 1001.952. Safe harbor protection is
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`afforded only to those arrangements that meet all the specific conditions set forth in the safe
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`harbor.
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`B.
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`The TRICARE Program
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`25.
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`TRICARE (formerly known as CHAMPUS) is a federal health care program,
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`as defined in the AKS, that is administered by DHA, a component of the DOD. TRICARE
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`provides health care insurance for active duty military personnel, military retirees, and
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`military dependents.
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`26.
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`TRICARE contracts with Express Scripts, Incorporated (“ESI”) to administer
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`its prescription drug coverage program, including processing and paying claims for
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`reimbursement from TRICARE for compounded prescription drugs.
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`27. At all relevant times, TRICARE covered compounded drugs that are
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`medically necessary and proven to be safe and effective. See 32 C.F.R. § 199.4(g)(15).
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`Compounding is the practice in which a licensed pharmacist or physician combines, mixes,
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`or alters the ingredients of a drug to create a medication tailored to the needs of an
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`individual patient. A patient may need a compounded drug, for example, if he or she is
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`allergic to an ingredient in a manufactured drug.
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`28.
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`From at least March 2014 to June 2015, TRICARE reimbursed pharmacies
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`for all the ingredients in a compounded drug. During this period, retail or mail-order
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`pharmacies generally were paid the “average wholesale price” of each ingredient in a
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`compounded drug minus a negotiated discount.
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`29. A provider, including a pharmacy or a physician, seeking reimbursement
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`from TRICARE must comply with TRICARE’s anti-fraud and abuse provisions. 32 C.F.R.
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`§ 199.9(a)(4). Fraudulent situations include commission and kickback arrangements with
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`independent contractors. Id. § 199.9(c)(12).
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`30.
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`Fraud or abuse by a pharmacy or physician may result in the denial of the
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`pharmacy or physician’s claims or the exclusion or suspension of the pharmacy or physician
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`from participation in the TRICARE program. 32 C.F.R. §§ 199.9(b), (f).
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 10 of 32
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`31.
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`TRICARE regulations specify that “[a]ll fraud, abuse, and conflict of interest
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`requirements [in section 199.9] are applicable to the TRICARE pharmacy benefits
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`program.” 32 C.F.R. § 199.21(p). TRICARE’s contract with ESI also incorporates the
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`provisions of 32 C.F.R. § 199.
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`32.
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`To receive reimbursement from TRICARE for compounded drugs, a
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`pharmacy must enter into a Provider Agreement with ESI, TRICARE’s pharmacy benefits
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`manager.
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`33.
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`ESI’s Provider Agreements incorporate ESI’s Provider Manuals as part of
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`those agreements. The ESI Provider Manuals in effect during the relevant time period
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`required pharmacies to be aware of and comply with all state and federal law, “including
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`anti-kickback statutes.” The Manuals warned that “[f]ailure to demonstrate compliance
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`with these laws may result in immediate termination by [ESI].”
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`34. As a condition of payment by TRICARE, a pharmacy must comply with the
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`AKS and must not offer or pay anything of value to third parties in exchange for referring,
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`recommending, or arranging for the referral of TRICARE patients for prescriptions to be
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`filled by the pharmacy and reimbursed by TRICARE.
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`35. DHA has exercised its authority to suspend providers under investigation for
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`fraud and abuse, including the payment of kickbacks.
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`36.
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`Each compounded drug claim submitted by a pharmacy for reimbursement
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`from TRICARE generally includes specific representations about the date of service, the
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`patient on whose behalf payment is being sought, the provider who prescribed the
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`medication, and the individual ingredients contained in the compounded drug.
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`23
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`C.
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`The CHAMPVA Program
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`37.
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`CHAMPVA is a federal health care program, as defined in the AKS, that is
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`administered by VHAOCC, a component of the VA. CHAMPVA provides health care
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`insurance for the qualifying spouses and children of veterans with service-connected
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`disabilities.
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 11 of 32
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`38.
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`CHAMPVA contracts with OptumRx, Incorporated (“OptumRx”) to
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`administer its prescription drug coverage program, including the processing and payment of
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`claims for reimbursement from CHAMPVA for compounded prescription drugs.
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`39. At all relevant times, CHAMPVA covered compounded drugs that are
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`medically necessary and proven to be safe and effective. See 38 C.F.R. § 17.272(a)–(b).
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`40.
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`From at least January 2014 to November 2015, CHAMPVA reimbursed
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`pharmacies for all the ingredients in a compounded drug. During this period, retail or mail-
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`order pharmacies generally were paid the “average wholesale price” of each ingredient in a
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`compounded drug minus a negotiated discount.
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`41.
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`Like with all other federal programs, a pharmacy seeking reimbursement from
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`CHAMPVA must comply with all applicable anti-fraud and abuse provisions, including the
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`FCA and AKS.
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`42.
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`CHAMPVA’s Program Guide encourages CHAMPVA beneficiaries to report
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`providers engaging in fraud and abuse and provides that providers who engage in fraud and
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`abuse may be sanctioned by the Department of Health and Human Services. U.S.
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`Department of Veterans Affairs, CHAMPVA Program Guide 73, 75 (June 2017), available at
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`https://www.va.gov/COMMUNITYCARE/docs/pubfiles/programguides/champva_guid
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`e.pdf.
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`43. As a condition of payment by CHAMPVA, a pharmacy must comply with
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`the AKS and must not offer or pay anything of value to third parties in exchange for
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`referring, recommending, or arranging for the referral of CHAMPVA patients for
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`prescriptions to be filled by the pharmacy and reimbursed by CHAMPVA.
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`44.
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`Each compounded drug claim submitted by a pharmacy for reimbursement
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`from CHAMVA generally includes specific representations about the date of service, the
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`patient on whose behalf payment is being sought, the provider who prescribed the
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`medication, and the individual ingredients contained in the compounded drug.
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 12 of 32
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`V.
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`Factual Background
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`A.
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`Pinnacle’s Kickback Relationships with Third-Party Marketers
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`45.
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`The Venturas and Jimenez owned and operated Pinnacle Compounding
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`Pharmacy, located in Las Vegas, Nevada, from at least January 2014 through at least
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`November 2015. The Venturas and Jimenez were at all times the owners of Pinnacle. In
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`addition to owning the pharmacy, the Venturas and Jimenez oversaw and substantially
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`participated in Pinnacle’s operations, including marketing, financial control, and claims
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`submission.
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`46.
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`Pinnacle, at the direction of the Venturas and Jimenez, entered into
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`agreements with independent third-party “marketers,” pursuant to which those marketers
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`were paid substantial kickbacks to generate prescriptions for compounded drugs, including
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`compounded topical creams, and arrange for those prescriptions to be referred to Pinnacle,
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`for which Pinnacle could then seek payment from the patient’s insurance, including
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`TRICARE and CHAMPVA.
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`47.
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`The Venturas and Jimenez agreed for Pinnacle to pay those marketers
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`substantial portions of the revenue, including TRICARE and CHAMPVA revenue, that the
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`marketers successfully generated for the pharmacy as a result of those referrals. One of the
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`primary marketers with whom Pinnacle worked was Gomez and Gomez’s two businesses:
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`Gomez & Associates and Rock’n Rob Enterprises. The Venturas and Jimenez were
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`responsible for negotiating and approving the various agreements between Pinnacle and
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`Gomez, and the Venturas and Jimenez continued to oversee Pinnacle’s relationships with
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`Gomez and other third-party marketers throughout the course of their kickback
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`arrangements. The Venturas and Jimenez agreed to pay these marketers substantial
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`kickbacks because of the large volume of referrals the marketers could bring to Pinnacle. As
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`a result of these relationships, Pinnacle received prescriptions for, and shipped compounded
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`drugs to, patients located throughout the United States.
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`48.
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`In May 2014, Cecilia Ventura, acting on behalf of Pinnacle entered into a
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`“Consulting Fee Agreement” with Gomez and Rock’n Rob Enterprises. Pursuant to that
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 13 of 32
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`agreement, the Venturas and Jimenez agreed to share all revenue from prescriptions that
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`Gomez solicited and referred to Pinnacle. The agreement provided that Pinnacle would pay
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`Gomez and Rock’n Rob Enterprises “thirty-five percent (35%) of the gross amount to
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`reimbursed by insurance companies . . . for prescriptions that come from Consultant’s
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`Prospective Accounts that are compounds[.]”
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`49.
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`The Venturas and Jimenez knowingly and willfully designed this arrangement
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`with Gomez to induce him to refer prescriptions to Pinnacle or arrange for or recommend
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`the ordering of compounded drugs from Pinnacle, so that the Venturas and Jimenez
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`through Pinnacle could then seek payment for those drugs from insurers like TRICARE and
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`CHAMPVA. Pursuant to each agreement, Pinnacle only compensated these marketers
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`when and if prescriptions were actually referred to Pinnacle. Additionally, the agreements
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`provided that Gomez’s compensation would be tied directly to the volume and value of the
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`prescriptions he referred to Pinnacle. Under the terms of the Consulting Fee Agreement,
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`Gomez only received compensation for prescriptions for compounded medications he
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`referred to Pinnacle. Gomez did not receive compensation for non-compounded
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`medications referred to Pinnacle.
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`50. At no time was there an employment relationship between Pinnacle and
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`Gomez. Gomez’s Consulting Fee Agreement stated that Gomez and Pinnacle’s “status is,
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`and at all times will continue to be, that of independent contractors with respect to each
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`other.” The Venturas and Jimenez knew that there was no employment relationship with
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`Gomez.
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`51.
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`Pinnacle’s “marketing” agreement with Gomez was simply an arrangement
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`pursuant to which the Venturas and Jimenez agreed to pay third parties for the referral of
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`prescriptions – a practice they knew was wrongful and illegal.
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`52. A purpose of the agreement was to induce Gomez to refer, or arrange for the
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`referral of, prescriptions to Pinnacle. Gomez’s Consulting Fee Agreement expressly
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`provided that Gomez would submit to Pinnacle “accounts and physician profiles, including
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`contact information” which Gomez believed would send business to Pinnacle because of
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`Case 2:21-cv-00184 Document 1 Filed 02/02/21 Page 14 of 32
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`Gomez. The Consulting Fee Agreement stated that this information, which would enable
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`the Venturas and Jimenez to solicit and pay for referrals would be sent to “Brandon
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`[Jimenez] and Cecilia [Ventura]’s email.”
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`53.
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`The substantial commissions agreed to by the Venturas and Jimenez
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`incentivized Gomez and other third-party marketers to increase both the value and volume
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`of the prescriptions they generated and referred to Pinnacle, regardless of patient need.
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`54. One way in which these marketers sought to increase prescription volume
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`was to identify, obtain, and refer prescriptions for formulas that would generate as large of a
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`payment as possible for the pharmacy, and in turn a larger kickback for the marketer,
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`regardless of whether the specific formulation was medically necessary. Notably, such
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`conduct is inconsistent with the purpose of compounding, which is to tailor medications to
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`the specific needs of individual patients.
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`55.
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`The Venturas and Jimenez, through Pinnacle, further encouraged this
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`practice by instructing their employee pharmacists to use more expensive ingredients in its
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`compounded prescriptions, even though less expensive ingredients could be used. The
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`Venturas and Jimenez through Pinnacle then provided pre-printed prescription pads to its
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`marketers, including Gomez.
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`56. Many, if not all, of the TRICARE and CHAMPVA beneficiaries who
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`received compounded medications from Pinnacle did not meet with the prescribing
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`physician, pay a co-pay for the medications, despite a co-pay requirement under TRICARE
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`and CHAMPVA’s respective policies, receive instructions on how to use the medications
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`from the prescribing physician, or need or use the expensive compounded medications they
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`received. Many of the TRICARE and CHAMPVA beneficiaries recalled receiving a
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`compounded pain cream and a compounded scar cream from