Justia Health Law Opinion Summaries
Articles Posted in US Court of Appeals for the Fifth Circuit
R.J. Reynolds v. FDA
The Food and Drug Administration denied Petitioner R.J. Reynolds Vapor Company’s (“RJRV”) application to market menthol-flavored e-cigarettes. Petitioners so ughta stay pending review of the denial order on the merits. RJRV petitioned the FDA for a stay, which was denied. RJRV and three other companies then petitioned the Fifth Circuit for review and moved to stay the Denial Order.
The Fifth Circuit entered a full stay pending resolution of RJRV’s petition on the merits. The court explained that the FDA’s disregard for the principles of fair notice and consideration of reliance interests is exacerbated by its failure to consider alternatives to denial. When an agency changes course, as the FDA did here, it must take into account “alternatives that are within the ambit of the existing policy.” Here, the court wrote, the FDA gave RJRV no such opportunity for its menthol PMTA. Further, the court explained that the FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. Moreover, the court found that RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. The court also held that given RJRV’s uncontested allegations and legal arguments, RJRV has met its burden of showing irreparable harm if denied a stay pending appeal. View "R.J. Reynolds v. FDA" on Justia Law
In re: Grand Jury Subpoena
An individual and an advocacy group seek to appeal from the denial of a motion to quash two grand jury subpoenas and an order compelling compliance with one of them. There is no jurisdiction for appeals challenging a grand jury subpoena for production of documents unless (1) the appellant has been held in contempt, or (2) a client-intervenor asserts that documents in the possession of a subpoenaed, disinterested third party are protected by attorney-client privilege.
The Fifth Circuit dismissed the appeal explaining that neither exception applied. The court explained that the subpoenaed documents are in the hands of Appellants. They are interested third parties in that they are being investigated for witness tampering. They have a direct and personal interest in suppressing the documents that could potentially corroborate the witness tampering accusation. Consequently, Appellants obviously have “a sufficient stake in the proceeding to risk contempt by refusing compliance.” Accordingly, the court wrote it lacks jurisdiction over the appeal, and Appellants must either comply with the subpoena or be held in contempt to seek the court’s review. View "In re: Grand Jury Subpoena" on Justia Law
Franciscan Alliance v. Becerra
Section 1557 of the Patient Protection and Affordable Care Act prohibits health care programs that receive federal funds from discriminating against patients on the basis of sex. Section 1557 incorporates Title IX’s definition of prohibited sex discrimination. The Secretary of HHS has authority to issue regulations to implement Section 1557.In May 2016, HHS issued a rule interpreting Section 1557’s prohibition of “discrimination on the basis of sex.” Plaintiffs claimed the rule violated the Administrative Procedure Act (APA) by defining “sex discrimination” inconsistently with Title IX. Initially, the district court issued a nationwide preliminary injunction and ultimately granted summary judgment to Plaintiffs but denied permanent injunctive relief. Significant litigation followed.In this case, HHS argues that any challenge to the 2016 Rule is now moot because the district court already vacated the parts of the rule that violated the APA, and because the 2020 Rule rescinded the 2016 Rule. The Fifth Circuit agreed. View "Franciscan Alliance v. Becerra" on Justia Law
USA v. Rodriguez
Defendant owned and operated a healthcare clinic. Along with another provider, Defendant engaged in a scheme to fraudulently bill Medicare for home health services that were not properly authorized, not medically necessary, and, in some cases, not provided. Insiders testified to Defendant's role in the conspiracy, indicating she knew the home healthcare agencies were paying marketers to recruit patients. Defendant also told an undercover FBI agent she could show him how to make money by recruiting patients. Defendant was convicted and sentenced to 300 months in federal prison.Defendant appealed, challenging the sufficiency of the evidence against her. However, the Fifth Circuit affirmed her conviction, finding that a rational jury could have concluded that Defendant knew about and willfully joined the conspiracy. Additionally, the court rejected Defendant's challenges to her sentence, finding that the district court did not commit a procedural error and that her sentence was not substantively unreasonable. View "USA v. Rodriguez" on Justia Law
LA Indep Pharmacies v. Express Scripts
The Louisiana Independent Pharmacies Association (“LIPA”) sued Express Scripts on behalf of its members, seeking a declaratory judgment on whether La. Rev. Stat. Ann. Sections 22:1860.1 and 46:2625 are preempted by Medicare Part D.1 Express Scripts moved to dismiss LIPA’s request for declaratory judgment regarding the reimbursement provision for failure to state a claim, see Fed. R. Civ. P. 12(b)(6), on the basis that Medicare Part D preempts the reimbursement provision for prescriptions covered by Part D plans The district court concluded, however, that Express Scripts failed “to meet its burden of showing preemption or any other basis for dismissal.” Express Scripts moved to certify the order denying its motion to dismiss for interlocutory appeal under 28 U.S.C. Section1292(b). The district court granted certification,
The Fifth Circuit vacated the district court’s order concluding that the court lacks both federal question and diversity jurisdiction. The court explained that here, LIPA seeks a declaration that Express Scripts’ state law and related contractual obligation to reimburse LIPA’s member pharmacies for the provider fee is not preempted by federal law. Applying the well-pleaded complaint rule requires the court to imagine a hypothetical coercive lawsuit brought by Express Scripts against LIPA’s member pharmacies. But none is conceivable, thus, because Express Scripts has no possible ground for a coercive lawsuit, no federal question arises for purposes of jurisdiction in LIPA’s declaratory judgment case. Accordingly, the court concluded that LIPA must make the same showing to satisfy the amount in controversy requirement. View "LA Indep Pharmacies v. Express Scripts" on Justia Law
USA v. Cooper
Defendant and several others were indicted on various healthcare fraud offenses stemming from a scheme in which Defendant and others would pay TRICARE beneficiaries to order certain creams and vitamins. At a jury trial, Defendant was convicted of one count of conspiracy to commit health care fraud, one count of receiving an illegal kickback payment, and six counts of making illegal kickback payments. The District Court sentenced Defendant to 240 months imprisonment.On appeal, Defendant challenged, among other things, the sufficiency of the evidence pertaining to his convictions for paying illegal kickbacks. The Fifth Circuit agreed with Defendant's reasoning that he did not "induce" TRICARE beneficiaries to order the substances by paying them because the substances were for their own use. Thus, the court reversed Defendant's convictions for paying illegal kickback payments. The court affirmed Defendant's other convictions and remanded for resentencing. View "USA v. Cooper" on Justia Law
USA v. Hamilton
Defendant was convicted of conspiracy to commit healthcare fraud, conspiracy to solicit and receive healthcare kickbacks, and two counts of false statements relating to healthcare matters. On appeal, Defendant challenged the sufficiency of evidence and her sentence.
The Fifth Circuit affirmed Defendant’s conviction and sentence. The court explained that the government was required to prove beyond a reasonable doubt “(1) an agreement between two or more persons to pursue an unlawful objective; (2) the defendant’s knowledge of the unlawful objective and voluntary agreement to join the conspiracy; and (3) an overt act by one or more of the members of the conspiracy in furtherance of the objective of the conspiracy.” The evidence was sufficient to prove that Defendant made an agreement to and did receive $60 kickbacks in exchange for home healthcare certifications. Thus, it was not unreasonable for the jury to conclude that the $60 payments were kickbacks, rather than legitimate co-pays, based on the evidence that patients rarely paid the fee, and that Defendant charged a uniform $60 fee regardless of the services rendered.
In Defendant’s challenge to the PSR’s calculation of the loss amount and its effect on her Sentencing Guidelines range, the court held that the district court did not err by overruling Defendant’s objection to the inclusion of Medicare Part A claims in the loss amount. However, the district court did err by overruling Defendant’s objection to the inclusion of the non-certification Medicare Part B claims in the loss amount because absent the fraud Medicare would have paid for these claims. Nonetheless, this error was harmless. View "USA v. Hamilton" on Justia Law
Vista Health Plan, Inc. v. United States Department of Health and Human Services
The Fifth Circuit affirmed the district court's grant of summary judgment in favor of the HHS Defendants in an action challenging HHS's risk-adjustment program, implemented under the Patient Protection and Affordable Care Act (ACA), and repromulgation of the 2017 and 2018 rules. In this case, Vista Health Plan, a health insurance company in Texas, was assessed risk-adjustment fees that exceeded its premium revenue, causing the company to cease operations.After determining that it has jurisdiction over the appeal, the court concluded that the 2017 and 2018 Final Rules adopted by HHS were not impermissibly retroactive under Landgraf v. USI Film Prods., 511 U.S. 244, 268 (1994). The court also concluded that HHS's failure to follow the Administrative Procedure Act's notice-and-comment procedures in its repromulgation of the 2017 Final Rule was at worst harmless error. Rather, the new rule actually maintained the settled expectations of insurers covered by the previous version of the rule. Finally, the court concluded that Vista's other issues on appeal regarding the administrative record before the district court, Chevron deference as to HHS's interpretation of the governing law, and the district court's "sua sponte" summary judgment on Vista's regulatory taking claim lack merit. View "Vista Health Plan, Inc. v. United States Department of Health and Human Services" on Justia Law
U.S. Navy SEALs 1-26 v. Biden
The Fifth Circuit denied defendants' motion for a partial stay of the district court's preliminary injunction enjoining the Department of Defense, United States Secretary of Defense Lloyd Austin, and United States Secretary of the Navy Carlos Del Toro from enforcing certain COVID-19 vaccination requirements against 35 Navy special warfare personnel and prohibiting any adverse actions based on their religious accommodation requests. Specifically, defendants seek a partial stay pending appeal insofar as the injunction precludes them from considering plaintiffs' vaccination statuses "in making deployment, assignment and other operational decisions."The court weighed the Mindes abstention factors and determined that this dispute is justiciable. However, the court concluded that defendants have not carried their burden to warrant the issuance of the stay. The court agreed with the district court that defendants have not shown a compelling interest to deny religious accommodations under the Religious Freedom Restoration Act of 1993 to each of the 35 plaintiffs at issue. Rather, the "marginal interest" in vaccinating each plaintiff appears to be negligible and thus defendants lack a sufficiently compelling interest to vaccinate plaintiffs. The court also concluded that the preliminary injunction does not irreparably damage the Navy and the public; partially staying the preliminary injunction pending appeal would substantially harm plaintiffs; and issuance of the requested stay would disserve the public interest. View "U.S. Navy SEALs 1-26 v. Biden" on Justia Law
D&G Holdings, LLC v. Becerra
D&G, a Medicare service provider for nursing homes and homebound individuals, filed suit against the H.H.S. Secretary in federal court seeking repayment of recouped funds, which then amounted to $4,136,258.19 in principal and $593,294.54 in accrued interest. The district court dismissed D&G's case for lack of subject matter jurisdiction, holding that there was no federal court jurisdiction pursuant to 42 U.S.C. 405(g), as applied to Medicare appeals by 42 U.S.C. 1395ff(b)(1)(A).The Fifth Circuit held that "effectuations" of final agency decisions when sought to liquidate the amount of repayment owed, are reviewable under 42 U.S.C. 405(g) as continuous aspects of the initial, properly exhausted, administrative decision. The court concluded that the district court had jurisdiction under section 405(g) to resolve this dispute because "effectuations" are inextricably intertwined with the initial exhausted agency action. Therefore, the district court committed reversible error when it granted the Secretary' motion to dismiss. Furthermore, the Secretary's attempted reopening of the "effectuation" was untimely and the purported reopening was void ab initio. The court reversed and remanded for further proceedings. View "D&G Holdings, LLC v. Becerra" on Justia Law