in Re Shire PLC, Baxter International Inc., Baxalta Incorporated, and ViroPharma Inc.

Court of Appeals of Texas·Decided August 6, 2021·No. 06-21-00016-CV·Published

Opinion

In The Court of Appeals Sixth Appellate District of Texas at Texarkana

No. 06-21-00016-CV

IN RE SHIRE PLC, BAXTER INTERNATIONAL INC., BAXALTA INCORPORATED, AND VIROPHARMA INC.

Original Mandamus Proceeding

Before Morriss, C.J., Burgess and Stevens, JJ. Opinion by Justice Burgess OPINION

In the trial court below, the real party in interest, Health Choice Advisory, LLC (HCA),

brought a qui tam action under the Texas Medicaid Fraud Prevention Act (TMFPA) against Shire

PLC, Baxter International Inc., Baxalta Incorporated, and ViroPharma Inc. (collectively Shire).

Shire moved the trial court to dismiss the action under Rule 91a of the Texas Rules of Civil

Procedure. The trial court denied the motion, and Shire filed this petition for a writ of

mandamus asking us to compel the trial court to grant its motion to dismiss. For the reasons

discussed below, we deny the petition.

I. Factual and Procedural History

A. The TMFPA and the Present Action

The TMFPA states,

A person commits an unlawful act if the person:

....

(5) except as authorized under the Medicaid program, knowingly pays, charges, solicits, accepts, or receives, in addition to an amount paid under the Medicaid program, a gift, money, a donation, or other consideration as a condition to the provision of a service or product or the continued provision of a service or product if the cost of the service or product is paid for, in whole or in part, under the Medicaid program . . . .

TEX. HUM. RES. CODE ANN. § 36.002(5). This provision is known as the “anti-kickback

section” of the TMFPA.

Section 36.011(a), subsections (2) and (3), provide that “a person acts ‘knowingly’”

under the TMFPA “if the person . . . (2) acts with conscious indifference to the truth or falsity of

the information[] or (3) acts in reckless disregard of the truth or falsity of the information.” TEX.

2 HUM. RES. CODE ANN. § 36.0011(a)(2)–(3). Section 36.101 of the TMFPA allows private

persons to institute suits for civil remedies for violations of the Act “in the name of the person

and of the state.” TEX. HUM. RES. CODE ANN. §§ 36.101(a), 36.052. The petition in suits

instituted by private persons must be filed in camera and served on the Texas Attorney General,

and the suit must remain under seal until the earlier of the date on which the Attorney General

elects to intervene and prosecute the action or 180 days after the date the petition was filed. TEX.

HUM. RES. CODE ANN. § 36.102(a), (b) (Supp.), § 36.104(a), (b).

In its petition in this case, HCA alleged that Shire violated the anti-kickback section of

the TMFPA by implementing two marketing programs that incentivized medical providers to

prescribe certain pharmaceutical products covered by the Texas Medicaid Program. According

to HCA, Shire provided nursing and support staff services to medical providers in exchange for

the providers prescribing the covered products; it also alleged that, by virtue of these programs,

Shire reduced the medical providers’ attendant expenses, thereby increasing their profit margins

for prescribing the covered products. HCA further alleged that, by increasing the providers’

profit margins, these two programs constituted illegal kickbacks to the medical providers.

Specifically, HCA alleged that, “in typical quid pro quo fashion,” the medical providers would

have to prescribe the covered products to obtain the identified support services.1

1 Among other things, HCA alleged in its petition that Shire 47. . . . . [E]ngaged in two schemes to induce recommendations by giving something of value to Prescribers for the purpose of inducing recommendations of the Covered Products. 48. In the first scheme, Defendants, with assistance from third-parties, provided the services of skilled nurses, for free, in part to induce Prescribers to recommend [the covered products] to their patients. 49. In the second scheme, Defendants, with substantial assistance from third parties, provided in-kind remuneration in the form of reimbursement support services, saving Prescribers thousands of dollars in administrative expenses, in part to induce Prescribers to recommend the Covered Products. 3 B. The Motion to Dismiss

Shire moved to dismiss this suit in the trial court under Rule 91a of the Texas Rules of

Civil Procedure. It alleged that HCA is “an affiliate of the National Health Care Analysis Group

(NHCA Group), an agency created by investors and former Wall Street Investment Bankers for

the purpose of pursuing false claims act litigation.” Shire further argued that in “2016 and 2017,

acting through various shell companies, NHCA Group filed numerous, virtually identical qui tam

actions across the country, against dozens of pharmaceutical companies.” Shire continued, “The

plaintiffs in those actions made the same allegations HCA makes here: that the defendants’

nurse-educator and reimbursement-support services amounted to illegal kickbacks that resulted

in the submission of fraudulent claims to federal and state healthcare programs.” Shire then

alleged (1) that “[t]he United States, however, flatly rejected NHCA Group’s theory and

exercised its authority under the False Claims Act [(FCA)]to dismiss the federal claims brought

by NHCA Group’s affiliates” and (2) that, “[i]n moving to dismiss those claims, the United

.... 60. Seeking to capitalize on the fact that follow-up and patient monitoring work is unprofitable for Prescribers, Defendants devised the free nurse program. Through this program, Defendants devised a scheme that allowed them to offer Prescribers the time, expertise, and resources of multiple “nurse educators” to provide follow-up care and relieve the Prescribers’ duty to monitor—all completely free of charge to the Prescribers. Given that the free nurses were performing medical services that the Prescribers or their staff would otherwise have been required to perform, the Nurse Support Services saved Prescribers a significant amount of money they otherwise would have incurred. .... 106. Given that the administrative tasks associated with the provision of Reimbursement Support Services are time-consuming, Prescribers are less likely to prescribe a drug that imposes an undue burden on support staff because doing so decreases profitability. Conversely, a Prescriber is much more likely to prescribe a drug if it can be prescribed with little or no administrative burden. 107. These factors were not lost on Defendants. Indeed, Defendants readily assumed the expense the Prescribers would otherwise have had to incur, knowing that the availability of Reimbursement Support Services would act as a powerful inducement to Prescribers to recommend the Covered Products over a competitor’s products, especially in Texas where reimbursement for administrative expenses associated with approval is prohibited. 4 States, through the Department of Justice, explained that the allegations lacked both ‘factual and

legal support’ and were an unfounded attack on ‘common industry practices’ that are

‘appropriate and beneficial to federal healthcare programs and their beneficiaries.’”

Shire asserted two arguments to the trial court in support of its motions to dismiss. First,

it argued that dismissal was required by the “public disclosure bar” of the TMFPA “because

[RPI’s] claims are based on allegations or transactions that were publicly disclosed—and thus

available to state prosecuting authorities—well before HCA filed its petition in this case.”2

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in Re Shire PLC, Baxter International Inc., Baxalta Incorporated, and ViroPharma Inc., (Tex. Ct. App. 2021).

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