Total Toxicology Labs, LLC v. United States Department of Health and Human Services, Secretary of

CourtDistrict Court, E.D. Michigan
DecidedDecember 23, 2019
Docket2:19-cv-12000
StatusUnknown

This text of Total Toxicology Labs, LLC v. United States Department of Health and Human Services, Secretary of (Total Toxicology Labs, LLC v. United States Department of Health and Human Services, Secretary of) is published on Counsel Stack Legal Research, covering District Court, E.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Total Toxicology Labs, LLC v. United States Department of Health and Human Services, Secretary of, (E.D. Mich. 2019).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION Total Toxicology Labs, LLC, Plaintiff, v. Civil Case No. 19-12000 Alex M. Azar, II. Secretary of the Sean F. Cox United States Department Of Health United States District Court Judge and Human Services, et al., Defendants. _________________________________/ OPINION & ORDER DENYING PLAINTIFF’S MOTION FOR PRELIMINARY INJUNCTION The plaintiff in this case, Total Toxicology Labs, LLC d/b/a TT Labs, LLC (“TT Labs”), provides clinical laboratory services to patients nationwide and is a participant in the Medicare Payment Process within the Medicare reimbursement system. As a participant in that system, TT Labs is subject to audits of its billings. In 2017, TT Labs learned that government auditors found that it had overcharged for services provided to Medicare beneficiaries. TT Labs challenged the auditors’ decisions at two levels of the Medicare administrative appeals process but, after those appeals, TT Labs was still found to have been overpaid for its services. TT Labs pursued an appeal at the third level of review, but has not yet been given a hearing date because the system is backlogged such that instead of receiving a hearing in 90 days, it could take three years or more for that administrative appeal to take place. Meanwhile, the Government has begun to start recouping the money that the audits showed were overpaid to TT Labs, as the regulatory scheme allows. The government recovers the amount due from the money that it 1 would otherwise pay for new reimbursement claims until the service provider’s debt is paid in full. The Government contends that TT Labs currently owes it a significant balance for overpayments, that it intends to recoup going forward. Not wanting to wait three years for the

third-level administrative appeal, and not having sought a hardship exception or pursuing other options under the regulatory scheme, such as escalation procedures, TT Labs filed this action asserting a due process claim and seeking a preliminary injunction. It asks this Court to enjoin the Government from any further recoupment until such time as it gets a third-level administrative appeal heard and decided. At an early status conference, counsel advised the Court that a federal district court in Tennessee had issued a preliminary injunction in a similar case with another Medicare service provider, A1 Diabetes, and that a decision on the appeal in that case would likely decide several of the issues in play here. The United States Court of Appeals for the Sixth Circuit, however,

did not rule on the issues and, instead, issued a decision wherein it identified a host of questions and concerns that need to be addressed before a decision on an preliminary injunction in this kind of case could be made. Thus, the Sixth Circuit vacated the district court’s preliminary injunction and remanded so that the parties and district court could address the various issues and questions it identified. The motion in this case has been fully briefed and TT Labs has not requested an evidentiary hearing. This Court heard oral argument on December 17, 2019. As explained below, TT Labs has not answered all of the various questions raised in A1 Diabetes as to the

factors to be considered relating to the likelihood of success on the merits of its due process 2 claim. And, even if it had, and the answers weighed in its favor such that it established a substantial likelihood of success on the merits of its due process claim, then this Court would still have to evaluate the other preliminary injunction factors. That includes the critical factor of the risk of irreparable harm to the plaintiff absent the requested injunctive relief. Although TT

Labs has a theoretically plausible claim of serious financial injury absent the requested injunction, it has failed to make the requisite evidentiary showing of certain and immediate irreparable financial harm needed to obtain a preliminary injunction. As such, the Court shall DENY the motion. BACKGROUND Plaintiff TT Labs filed this action against Defendant Alex M. Azar, II, Secretary of the United States Department of Health and Human Services and Seema Verma, Administrator for the Centers for Medicare and Medicaid Services (“the Government”) asserting the following three counts: 1) “Denial Of Procedural Due Process” (Count I); 2) “Ultra Vires” (Count II); and

3) “Violation Of The Administrative Procedures Act” (Count III). TT Labs’s complaint alleges that the Government’s “recoupment of the alleged overpayment has already caused Plaintiff devastating financial harm its continuance will cause continued financial harm, and possibly force Plaintiff out of business well before any ALJ could hear and decide the case pursuant to statutory administrative review. Without the temporary relief requested herein, Plaintiff is likely to suffer the fatal consequence of permanent closure.” (Compl. at ¶ 41). Pending before the Court is a motion filed by TT Labs seeking a preliminary injunction. TT Labs asks this Court to enjoin the Government “from any further recoupment or collection of

alleged Medicare overpayments, including referral to the U.S. Treasury Department for 3 collection, until such time as an administrative law judge assigned to the Office of Medicare Hearings and Appeals (‘OMHA’) hears Plaintiff’s pending appeal and renders a decision thereon.” (ECF No. 3 at PageID.156). TT Labs’s motion does not request an evidentiary hearing. Rather, TT Labs states that its

“Motion is based on the facts sworn in the Verified Complaint filed in this action and the exhibits attached thereto, and the Brief in Support filed herewith, and applicable law.” (ECF No. 3 at PageID.156) (emphasis added). There are no declarations or affidavits attached as exhibits to the motion. TT Labs’s complaint is titled, “Verified Complaint For Temporary Restraining Order And Preliminary Injunction.” (ECF No. 1) (emphasis added). A verified complaint has the same force and effect as a signed and notarized affidavit. Williams v. Browman, 981 F.2d 901, 905 (6th Cir. 1992). Its title notwithstanding, TT Labs’s complaint was neither accompanied by a sworn statement nor attested to under oath, and thus it is not a verified complaint. See El Bey v.

Roop, 530 F.3d 407, 414 (6th Cir. 2008) (noting that a “verified complaint” is one that is signed under the penalty of perjury pursuant to 28 U.S.C. § 1746); see also Williams, supra; 28 U.S.C. § 1746. TT Labs has not submitted any affidavits or declarations in support of its motion, such as an affidavit attesting to its financial condition or the impact of the recoupment on same. Soon after this case was filed, this Court held a status conference with counsel. Counsel advised the Court that a district court in Tennessee had granted a preliminary injunction in a

4 similar case against the Government, without holding an evidentiary hearing1, and in favor of another Medicare service provider, A1 Diabetes & Medical Supply. They further advised that an appeal before the Sixth Circuit in that case would very likely answer many of the same issues in this case, such as whether subject matter jurisdiction exists, whether a Medicare service provider

has a protected interest for purposes of a due process claim, and whether the issuance of a preliminary injunction is appropriate. The parties agreed to a briefing schedule as to the motion in this case. The Government filed a brief in opposition to the preliminary injunction motion.

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