United States v. Donofrio

CourtCourt of Appeals for the Fifth Circuit
DecidedMay 20, 2025
Docket24-40002
StatusUnpublished

This text of United States v. Donofrio (United States v. Donofrio) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fifth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Donofrio, (5th Cir. 2025).

Opinion

Case: 23-40586 Document: 194-1 Page: 1 Date Filed: 05/20/2025

United States Court of Appeals for the Fifth Circuit _____________ United States Court of Appeals Fifth Circuit No. 23-40586 consolidated with FILED No. 24-40002 May 20, 2025 _____________ Lyle W. Cayce Clerk United States of America,

Plaintiff—Appellee,

versus

Steven Donofrio,

Defendant—Appellant. ______________________________

Appeal from the United States District Court for the Eastern District of Texas USDC Nos. 5:19-CR-25-5 ______________________________

Before Ho, Engelhardt, and Douglas, Circuit Judges. Per Curiam: * Steven Donofrio was convicted of one count of violating 18 U.S.C. § 371, conspiracy to commit and abet certain offenses in violation of 42 U.S.C. § 1320a-7b, the Anti-Kickback Statute. He now appeals that conviction on numerous grounds, as well as his sentence and forfeiture judgment. For the reasons that follow, we AFFIRM the district court’s _____________________ * This opinion is not designated for publication. See 5th Cir. R. 47.5. Case: 23-40586 Document: 194-1 Page: 2 Date Filed: 05/20/2025

23-40586 c/w No. 24-40002

judgment of conviction. We VACATE Donofrio’s sentence and forfeiture judgment and REMAND for further proceedings. I The Anti-Kickback Statute (“AKS”) prohibits knowingly and willfully soliciting or receiving kickbacks, bribes, or rebates, directly or indirectly, in return for referring an individual for the furnishing of services or ordering any good, facility, or service that may be covered by a federal health care program. 42 U.S.C. § 1320a-7b(b)(1). It also prohibits any individual from offering or paying any such remuneration. Id. § 1320a- 7b(b)(2); see also United States v. Marchetti, 96 F.4th 818, 825 n.6 (5th Cir. 2024) (“The [§ 1320a-7(b)](1)/(2) distinction appears to be purely about the direction the money is flowing.”). Medicare is a qualifying health care program under the statute. 42 U.S.C. § 1320a-7b(f). A Vantari Genetics, LLC (“Vantari”), was a medical laboratory that performed pharmacogenetic tests (“PGx”), swab tests that identify how patients metabolize drugs. In 2014, its founder, Nicolas Arroyo, sought to grow the company’s reach and profitability by entering the Texas and Arizona markets. Vantari’s business model worked as follows: a contracted distributor would market Vantari’s product to doctors; once a doctor selected Vantari, they would swab the patient; the doctor would then package the swab and ship it to Vantari’s laboratory in Irvine, California, using a prepaid UPS label that came with the swab. Once the insurer was billed, Vantari would pay each distributor a percentage of reimbursements generated by the distributor, some of which was then paid by the distributor to its sub-representatives. As part of its expansion plan, Vantari approached Genematrix, a healthcare distributor that had recently been founded by Donofrio. Donofrio,

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hoping to grow Genematrix, considered this “a huge opportunity.” He tasked his attorney, Clay Patterson, with reviewing and assisting with the contract, but Patterson raised red flags regarding compliance with applicable regulations. Donofrio—who had experience in the medical field, had received AKS training, and was known as a “smart” and “seasoned” healthcare professional—also noticed some concerning language in the contract. On April 15, 2014, he emailed Arroyo, stating: “Is there someone else I should be handling this with on your side? I don’t want this to be a huge roadblock, but your contract did have a lot of red flags with regards to Medicare compliance. We probably need to have a call. Let me know.” Nevertheless, the concerning language remained. Once again, Patterson informed Donofrio of red flags: the agreement “fail[ed] to include necessary compliance language for AKS” and “contain[ed] multiple provisions . . . in direct contradiction of Medicare Regulations.” “Strictly from a legal” perspective, Patterson “strongly recommend[ed] against signing the Agreement”; however, “from a business” perspective, he understood “the need to enter the contract” and recommended doing so if his revisions were accepted. Donofrio signed the agreement. He responded to Patterson, stating that he agreed with his assessment, but that Genematrix was “a ship without a port right now” and that “[t]his may just be a temporary stop for [the company].” He emailed the agreement to Arroyo with the following transmittal language: “As I stated to you yesterday after our discussion, I made it clear to our attorney to stress business over legal.” He later testified that he believed the contract was legal and that Patterson was comfortable with the agreement. The contract provided for a thirty-five percent commission on reimbursements for all insurance payors.

3 Case: 23-40586 Document: 194-1 Page: 4 Date Filed: 05/20/2025

The contract was a success. Genematrix received over $2.4 million in payments as Donofrio and Arroyo established a lasting working relationship and, ultimately, friendship. Donofrio’s involvement transcended mere distributorship, at least from an outsider’s perspective—he was even provided a Vantari domain email address and business card. But, in due time, the agreement hit speedbumps. Vantari’s Chief Financial Officer sent an advisory opinion from the Department of Health and Human Services’ Office of Inspector General suggesting that Vantari’s arrangements with distributors were “essentially illegal.” Arroyo amended the contracts such that they only provided commissions for private payors, but incorporated new language that would pay a specified monthly rate for each “active” sub- representative who performed certain activities. The contract explicitly stated that there would be no commissions for federal reimbursements. This concerned Arroyo, whose business depended on large distributors earning federal commissions. He called Donofrio and explained the issue, and ultimately decided he would “find ways to pay for those federal claims one way or another.” He “tried everything in [his] power” to fix the issue, and informed “a handful of distributors, the largest ones, . . . that [he] would do everything in [his] power, . . . to try to shore up those differences.” Donofrio, for his part, attempted to settle down his employees who had grown concerned and restless. Ultimately, Arroyo found two ways to cover the lost federal reimbursement commissions. First, he paid lump sum “bonuses” to distributors for compliance training and contract signing. Arroyo testified that these bonuses were designed to cover lost federal reimbursements. Second, he implemented a “matching” process. Every month, a Vantari employee would work with distributors to report the number of “active reps” that were necessary to match the would-be federal

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reimbursements. This was “a sham” to cover federal reimbursements while “being compliant” with the AKS. The method was designed to cover any enforcement inquiries. Donofrio testified that he was unaware that the contracts were changed for compliance reasons, and instead merely went along with Vantari’s changes to ensure he got paid. Testimony at trial was conflicting.

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United States v. Donofrio, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-donofrio-ca5-2025.