Precise Diagnostics, LLC v. Xavier Becerra, Secretary, United States Department of Health and Human Services

District Court, N.D. Texas·Decided August 26, 2026·No. 3:23-cv-00461·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION

PRECISE DIAGNOSTICS, LLC, § § Plaintiff, § § v. § Civil Action No. 3:23-CV-0461-K § XAVIER BECERRA, Secretary, § UNITED STATES DEPARTMENT § OF HEALTH AND HUMAN § SERVICES, § § Defendant. §

MEMORANDUM OPINION AND ORDER Before the Court is Defendant Xavier Becerra’s Motion to Dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) (Doc. No. 16) (the “Motion to Dismiss”), to which Plaintiff Precise Diagnostics, LLC filed a response (Doc. No. 24) and Defendant replied (Doc. No. 27). Also before the Court is Plaintiff’s Motion for Leave to File a Sur-Reply (Doc. No. 28) (the “Motion for Leave”), to which Defendant filed a response (Doc. No. 29) and Plaintiff replied (Doc. No. 30). The Court has carefully considered both motions, the responses, replies, applicable law, and relevant portions of the record. For the following reasons, the Court concludes Plaintiff failed to properly channel its claims through the United States Department of Health and Human Services, thus depriving the Court of subject-matter jurisdiction. The Court also finds that allowing a sur-reply is unwarranted in this case. Therefore, the Court GRANTS the Motion to Dismiss and DENIES the Motion for Leave.

I. Factual and Procedural Background Plaintiff Precise Diagnostics, LLC is an independent clinical laboratory that participates in the Medicare program and provides laboratory services to Medicare beneficiaries in Dallas County. Pl.’s Compl. (Doc. No. 1) ¶¶ 4, 19 (all record citations

herein are to the document-assigned page or paragraph numbers). Medicare is a national health insurance program administered by the Centers for Medicare & Medicaid Services (“CMS”), which is an agency within the United States Department of Health and Human Services (“HHS”). Id. ¶ 5. As a Medicare provider, Plaintiff submits claims for payment to Novitas Solutions, a Medicare Administrative

Contractor. Id. ¶ 11. Those claims are subject to review by a Unified Program Integrity Contractor (“UPIC”) for suspected fraud, waste, abuse, and improper payments. Id. On May 13, 2022, the UPIC Qlarant Integrity Solutions, LLC issued a notice of suspension of Medicare payments to Plaintiff pursuant to 42 C.F.R.

§ 405.371(a)(2). Id. ¶ 22. According to Qlarant, Plaintiff had “misrepresented services billed to the Medicare program” and “did not submit records that showed the results were reviewed, considered in the treatment plan, or assisted in the management/treatment of the beneficiary per Local Coverage (LCD) guidelines.” Id. ¶ 25. Qlarant also asserted that the records submitted “were inconsistent (i.e., some

documentation referenced right foot great toe while other documentation for the same date of services referenced left foot second toe).” Id. In addition, Qlarant claimed the records did not support the medical necessity of the services billed. Id. As a result, all

Medicare payments owed to Plaintiff were withheld pending resolution of the ongoing investigation. Id. ¶ 23. On October 27, 2022, Qlarant sent Plaintiff a Notice of Termination of Suspension of Medicare Payments. Id. ¶ 27. Plaintiff alleges that, despite the termination letter, CMS continued to suspend its Medicare payments. Id. ¶ 28. While

the suspension was still ongoing, Defendant Xavier Becerra, in his capacity as then- Secretary of the HHS, issued two notices of Medicare overpayment to Plaintiff: a November 28, 2022, notice for $15,940.21, and a December 8, 2022, notice for $2,319,609.56. Id. ¶¶ 33–34.

Plaintiff filed suit regarding the May 2022 suspension and its continuation after the October 27, 2022, notice of termination. See generally id. Plaintiff alleges Defendant has illegally confiscated over $245,698.66 in suspended payments. Id. ¶¶ 2–3. Plaintiff brings claims for violation of its due process rights, id. ¶¶ 67–73, violation of its

patients’ due process rights and access to Medicare, id. ¶¶ 74–77, arbitrary and capricious actions by Defendant, id. ¶¶ 78–80, ultra vires withholding of Medicare payments, id. ¶¶ 81–83, and mandamus, id. ¶¶ 84–87. Plaintiff also requests a temporary restraining order, id. ¶¶ 88–94, preliminary injunction, id. ¶ 95, permanent injunction, id. ¶ 96, and declaratory relief, id. ¶ 97. Defendant moves to dismiss based

on Federal Rule of Civil Procedure 12(b)(1) for lack of subject-matter jurisdiction and 12(b)(6) for failure to state a claim upon which relief can be granted. See generally Doc. No. 16. Plaintiff also moves for leave to file a sur-reply, see generally Doc. No. 28, Pl.’s

Reply to Mot. for Leave (Doc. No. 30), which Defendant opposes, see generally Def.’s Resp. to Mot. for Leave (Doc. No. 29). II. Legal Standard “Federal courts are courts of limited jurisdiction, and absent jurisdiction conferred by statute, lack the power to adjudicate claims.” La. Real Est. Appraisers Bd.

v. Fed. Trade Comm'n, 917 F.3d 389, 391 (5th Cir. 2019) (quoting Texas v. Travis Cnty., 910 F.3d 809, 811 (5th Cir. 2018)). Courts “must presume that a suit lies outside this limited jurisdiction, and the burden of establishing federal jurisdiction rests on the party seeking the federal forum.” Howery v. Allstate Ins. Co., 243 F.3d 912, 916 (5th

Cir. 2001) (citing Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994)). Under Rule 12(b)(1), a party may challenge the subject-matter jurisdiction of the district court to hear a case. FED. R. CIV. P. 12(b)(1). The district court may dismiss for lack of subject-matter jurisdiction based solely on the complaint. Ramming v. United

States, 281 F.3d 158, 161 (5th Cir. 2001) (citing Barrera-Montenegro v. United States, 74 F.3d 657, 659 (5th Cir. 1996)). The court must accept all nonfrivolous allegations in the complaint as true, Randall D. Wolcott, M.D., P.A. v. Sebelius, 635 F.3d 757, 763 (5th Cir. 2011) (citing McClain v. Pan. Canal Comm’n, 834 F.2d 452, 454 (5th Cir. 1987)), and if the court determines that it lacks subject-matter jurisdiction, it must

dismiss the action, FED. R. CIV. P. 12(h)(3). If a case survives a Rule 12(b)(1) challenge, the court may then consider a Rule 12(b)(6) claim and other motions. See Alabama-Coushatta Tribe of Tex. v. United States,

757 F.3d 484, 487 (5th Cir. 2014). To survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). The alleged facts must be facially plausible such that the facts nudge the plaintiff’s claims “across the line from conceivable to plausible.” Id. at 570. If a plaintiff pleads factual content that allows the

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Precise Diagnostics, LLC v. Xavier Becerra, Secretary, United States Department of Health and Human Services, (N.D. Tex. 2026).

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