Caplin v. Trans1, Inc.

973 F. Supp. 2d 596, 2013 WL 5309743, 2013 U.S. Dist. LEXIS 134257
CourtDistrict Court, E.D. North Carolina
DecidedSeptember 19, 2013
DocketNo. 7:12-CV-23-F
StatusPublished

This text of 973 F. Supp. 2d 596 (Caplin v. Trans1, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Caplin v. Trans1, Inc., 973 F. Supp. 2d 596, 2013 WL 5309743, 2013 U.S. Dist. LEXIS 134257 (E.D.N.C. 2013).

Opinion

ORDER

JAMES C. FOX, Senior District Judge.

This matter is before the court on the Defendants’ (collectively, “TranSl”)1 motion to dismiss [DE-34].2 Plaintiffs (collectively, “Caplin”) have filed a response in opposition [DE-41], The motion has been fully briefed and is ripe for ruling.

I. PROCEDURAL AND FACTUAL BACKGROUND

Caplin initiated this action on January 4, 2012, by filing a Class Action Complaint [DE-1] alleging claims for violations of the federal securities laws. Caplin timely filed an Amended Class Action Complaint [DE-29], which TranSl now moves to dismiss. By its May 8, 2012 Order [DE-27], the court appointed Philip J. Singer as lead Plaintiff and the law firm Pomerantz, Haudek, Grossman & Gross, LLP as lead counsel.

For purposes of ruling on a Rule 12(b)(6) motion to dismiss, the court assumes that the well-pleaded factual allegations in the amended complaint are true. Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). The court therefore relates the facts as alleged in the amended complaint and as Caplin describes them in its response in opposition to the motion to dismiss [DE-41] (“Caplin Resp.”). The court notes that TranSl disputes much of Caplin’s version of the facts.

TranSl is a publicly-traded medical device company that designs, markets, and sells medical devices used in spinal procedures. The AxiaLIF line of products is the company’s primary source of revenue. AxiaLIF is a type of spinal surgery in which the surgeon performs spinal fusion and motion preserving surgeries utilizing a “pre-saeral approach.” The pre-sacral approach allows the patient to remain on his stomach throughout the procedure as the surgeon performs the procedure straight [600]*600up the tailbone. This procedure is different than most spinal surgeries, which utilize an “anterior” or frontal approach, where the surgery is performed through the frontal portion of the spine with the patient positioned on his back.

Utilization of the AxiaLIF procedure, and consequently the AxiaLIF line of products, is dependent on surgeons receiving reimbursement from third-party payors (health insurance providers). Thus, TranSl’s revenue is highly dependent on whether health insurance providers will reimburse for the procedure. As Caplin notes in his brief, “[i]f insurance companies refuse to reimburse surgeons for an AxiaLIF procedure, they will simply stop utilizing the device.” Caplin Resp. [DE-41] at 4.

TranSl initially obtained FDA approval to manufacture and sell the AxiaLIF line of products through the 510(k) approval process, which is less costly and rigorous than the typical FDA pre-market approval process for medical devices. Importantly, the 510(k) approval process requires less supporting research data regarding effectiveness than the traditional pre-market approval process.

After TranSl obtained FDA approval, it began the process of ensuring that surgeons would receive health insurance reimbursement for performing the AxiaLIF procedure and using the related medical devices. Insurance reimbursement decisions are dependent on the American Medical Association’s (AMA) “Current Procedural Terminology” (CPT) codes. The CPT system divides physician services into three distinct categories and eligibility for reimbursement for a particular procedure is often dependent on the procedure’s CPT code. Category III is typically reserved for newer or experimental procedures in which a limited amount of research data is available regarding safety and effectiveness. Various federal statutes require surgeons to use the appropriate CPT code on reimbursement forms.

Prior to 2009, surgeons could code the AxiaLIF procedure as an anterior fusion procedure under Category I and easily obtain reimbursement from insurance providers.3 In 2008, on the recommendation of the National Association of Spine Surgeons Reimbursement Coding Committee, the AMA changed the CPT code for AxiaLIF to Category III. Both the AMA and the National Association of Spine Surgeons were concerned about the lack of research data regarding the safety and effectiveness of the AxiaLIF procedure and the fact that the procedure did not employ the traditional anterior approach through the front of the spine. The new Category III CPT code became effective January 1, 2009. After the new designation, most insurance providers refused to reimburse surgeons performing the AxiaLIF procedure, allegedly “threatening the future viability of [TranSl].” Id. at 5.

Caplin alleges that in response to the Category III designation, TranSl engaged in a pervasive fraudulent scheme in which it “coached” physicians to avoid the Category III CPT code to obtain reimbursement for the AxiaLIF procedure. The fraudulent scheme involved multiple components: a reimbursement committee which presented information to surgeons regarding how to avoid or conceal the Category III designation; illicit conference calls with distributors in which TranSl instructed its distributors to advise sur[601]*601geons to use a Category I CPT code for the AxiaLIF procedure; training sessions and development of a coding template designed to “coach” surgeons to avoid or conceal the Category III designation; a reimbursement guide advocating various methods for concealing the Category III designation; and national meetings in which TranSl instructed physicians and other employees in various methods to avoid the Category III designation. Much of the evidence for the allegations comes from confidential witnesses who are former employees of the firm.

A. Reimbursement Committee

After the Category III designation was announced, TranSl’s senior management (the individual defendants) allegedly formed a “reimbursement committee” headed by Amy Conner. The reimbursement committee allegedly gave presentations to surgeons regarding how to fraudulently obtain reimbursement despite the Category III designation and created a hotline in which surgeons received telephonic coaching in which they were instructed to conceal the designation. The presentations and telephonic coaching advised surgeons to “bury” the Category III designation at the bottom of the reimbursement form so insurance providers would likely overlook the code and provide coverage. The confidential witnesses also report that Conner gave presentations to senior management regarding the process for avoiding the Category III designation.

B. Illicit Conference Calls with Distributors

The confidential witnesses also report that TranSl employees held conference calls with distributors of the AxiaLIF line of products in which employees encouraged distributors to advocate use of the Category I CPT designation to surgeons instead of the required Category III designation. TranSl advised the distributors to tell surgeons that all surgeons coded the AxiaLIF procedure in this manner, despite the AMA mandate. The confidential witness involved in these conference calls allegedly stated, “TranSl told us to do whatever we had to do [to get surgeons to use its product].” Id. at 8.

C. Training Sessions and Coding Template

TranSl also allegedly held onsite training sessions regarding coding procedures for AxiaLIF at locations where surgeons performed the procedure. Dr.

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Bluebook (online)
973 F. Supp. 2d 596, 2013 WL 5309743, 2013 U.S. Dist. LEXIS 134257, Counsel Stack Legal Research, https://law.counselstack.com/opinion/caplin-v-trans1-inc-nced-2013.