United States ex rel. Stepe v. RS Compounding LLC

304 F. Supp. 3d 1216
CourtDistrict Court, M.D. Florida
DecidedJanuary 10, 2018
DocketCase No. 8:13–cv–3150–T–33AEP
StatusPublished
Cited by4 cases

This text of 304 F. Supp. 3d 1216 (United States ex rel. Stepe v. RS Compounding LLC) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States ex rel. Stepe v. RS Compounding LLC, 304 F. Supp. 3d 1216 (M.D. Fla. 2018).

Opinion

VIRGINIA M. HERNANDEZ COVINGTON, UNITED STATES DISTRICT JUDGE

This matter comes before the Court pursuant to Defendant Stephen M. Caddick's Motion to Dismiss Relator's Second Amended Complaint (Doc. # 93), filed on December 12, 2017, and Defendants RS Compounding LLC and Renier Gobea's Motion to Dismiss Relator's Second Amended Complaint (Doc. # 97), filed on December 21, 2017. Relator McKenzie Stepe responded on January 4, 2018. (Doc. # 101). For the reasons that follow, the Motions are granted.

I. Background

A. Alleged False Claims Act Violations

Defendants Renier Gobea and Stephen Caddick, Pharm. D., co-founded Defendant RS Compounding LLC in 2004. (Doc. # 91 at ¶ 34). RS Compounding, which does business as Zoe Scripts Laboratory Services, LLC, and Westchase Compounding Pharmacy, is a compounding pharmacy that "distribute[s] massive quantities of pre-made compounds for both humans and animals throughout the country in a fashion similar to a large pharmaceutical manufacturing company." (Id. at ¶¶ 4, 6). Defendants market many types of creams and gels, some of which contain ketamine. (Id. at ¶ 7). "At least 40% and 50% of Defendants' sales and revenues are earned from Medicare and TRICARE reimbursements." (Id. at ¶ 5).

Caddick is a licensed pharmacist, but Gobea is not. (Id. at ¶¶ 34, 37). Although Gobea at one point sold his ownership interest to Caddick, Gobea returned "to serve in a senior level management position in or around early 2012." (Id. at ¶ 34). Subsequently, Gobea purchased Caddick's ownership interest in February of 2013. (Id. at ¶ 35). Thus, "Gobea is the current owner and director of RS Compounding." (Id. at ¶ 36). Nevertheless, after the sale of his ownership interest, Caddick remained to "serve[ ] as a senior manager, or sole manager, of [RS Compounding] until approximately *1219early 2015" and "oversaw all of RS Compounding's operations, including the training of RS Compounding's sales representatives." (Id. at ¶ 37). "Beginning in or around January 2013," Caddick and Gobea "would meet every Monday and Wednesday morning to discuss [RS Compounding's] operations." (Id. ).

Plaintiff relator McKenzie Stepe was "personally hired" by Caddick in November 2011 to work for RS Compounding as a sales representative in New York and New Jersey. (Id. at ¶ 29). "During her employment, she also had some communications with [ ] Gobea." (Id. ). Stepe resigned her position in February 2013. (Id. ). Through her work, Stepe alleges she became aware of various schemes committed by Defendants in order to increase reimbursements from the Government.

The first was a marketing scheme created by "Gobea and/or [ ] Caddick," which they called the "1, 2, 3 strategy." (Id. at ¶ 8). This scheme involved pre-printed script pads, listing RS Compounding's various creams and gels, along with sales representatives' "coaching" physicians to prescribe the most highly-reimbursed drugs. (Id. at ¶¶ 8, 13). According to Stepe, "Defendants [ ] Gobea and/or [ ] Caddick have instructed RS Compounding's sales representatives to fill in the physician's name, National Provider Identifier ('NPI') number, and to also write in '6' for the number of refills, regardless of actual patient need," on the pre-printed script pad. (Id. at ¶ 9). And, during Stepe's first year with RS Compounding, Defendants "required that their [script pads] contain prepopulated check marks for the most expensive compounds RS Compounding sold, thereby placing the burden on the prescribing physicians to cross out the check mark and check off another product." (Id. at ¶¶ 10, 17).

Stepe alleges that, as a result of these pre-printed script pads, "Defendants automatically ship refills to patients-often of the most expensive products if the physician did not cross out the check mark and check off a different compound-and seek TRICARE and Medicare reimbursements for those refills despite questionable (and unsupervised by a doctor) medical necessity." (Id. at ¶ 17). Stepe allegedly received "complaints from the physicians she worked with that some of their patients were angered by RS Compounding's automatic shipments of the six compounds and their billing for each compound, even though there was no medical need for the additional five compounds and the patient did not want the extra compounds." (Id. at ¶ 64). According to Stepe, "Defendants' scheme is fraudulent because it causes TRICARE and Medicare to reimburse Defendants ... for drugs that uni[n]formed physicians ordered in greater amounts than necessary along with several automatic refills." (Id. at ¶ 18).

In addition to the pre-printed script pads, "[u]nder the '1, 2, 3 strategy,' Defendants' sales representatives 'coach' physicians to number three products on the pre-printed script." (Id. at ¶ 13). Thus, for pre-printed script pads that did not include checkmarks by the most expensive drugs, Stepe alleges "[p]hysicians are coached to choose their top three preferences for each cream or gel based on the active ingredients." (Id. at ¶ 67). Sales representatives coach physicians to mark the most highly-reimbursed drugs with a "1," the second most highly-reimbursed drugs with a "2," and the third most highly-reimbursed drugs with a "3." (Id. at ¶¶ 68-70).

The importance of this numbering was emphasized to sales representatives by RS Compounding's Vice President of Sales and Marketing, Jon Taylor. He "instructed [them] to 'fill out a sample prescription and highlight how you are suggesting they fill it out.... Repeating your message on *1220this until it sticks." (Id. at ¶ 15). "Through this marketing scheme, Defendants also targeted geographical locations with high concentrations of military personnel in order to issue large quantities of compounding prescriptions ... knowing that TRICARE would reimburse the highly inflated costs." (Id. at ¶ 71).

According to Stepe, RS Compounding "directed its sales representatives to work with the IT staff or administrators handling their physicians' electronic medical records (EMR) systems to add the Company's compounds into the systems so that the compounds would be prepopulated and 'readily available to share with customers.' " (Id. at ¶ 11). "Although [RS Compounding's] written materials indicated that only non-controlled substance compounds were able to be E-scribed and controlled substance compounds (e.g., ketamine) had to be faxed or mailed, the Company accepted E-scribed controlled substance compounds." (Id. ).

Another scheme involved disparate pricing of the compounds and gels sold by Defendants, in which different patients were charged different amounts for the same substances. According to Stepe, "the Company charged vastly different prices for individuals who were uninsured, who had private insurance, and who were covered by TRICARE and Medicare." (Id. at ¶ 76).

Also, Stepe alleges Defendants "do not train their sales representatives regarding proper and improper use, or potential contra-indications or warnings." (Id. at ¶ 92).

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Bluebook (online)
304 F. Supp. 3d 1216, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-stepe-v-rs-compounding-llc-flmd-2018.